Expanding interbody implant and articulating inserter and methods of use

ABSTRACT

A device includes a first endplate having an engagement surface and first and second extensions. The first extension has a first ramp and the second extension has a first slot. A second endplate includes a second engagement surface and third and fourth extensions. The third extension has a second ramp and the fourth extension has a second slot. A wedge is positioned between the endplates and includes a first inclined portion that engages the first ramp and a second inclined portion that engages the second ramp. The wedge has first and second apertures. A first pin extends through the first aperture and the first slot. A second pin extends through the second aperture and the second slot. The wedge is movable relative to the endplates to move the device from a first height to an increased second height. Methods of use are disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/480,718, filed on Apr. 6, 2017, which is hereby expresslyincorporated herein by reference, in its entirety.

TECHNICAL FIELD

The present disclosure generally relates to medical devices, systems andmethods for the treatment of musculoskeletal disorders, and moreparticularly to an expandable interbody implant system and method fortreating a vertebral column.

BACKGROUND

Spinal disorders such as degenerative disc disease, disc herniation,osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvatureabnormalities, kyphosis, tumor, and fracture may result from factorsincluding trauma, disease and degenerative conditions caused by injuryand aging. Spinal disorders typically result in symptoms including pain,nerve damage, and partial or complete loss of mobility. For example,after a disc collapse, severe pain and discomfort can occur due to thepressure exerted on nerves and the spinal column.

Non-surgical treatments, such as medication, rehabilitation and exercisecan be effective, however, may fail to relieve the symptoms associatedwith these disorders. Surgical treatment of these spinal disordersincludes fusion, fixation, discectomy, laminectomy and implantableprosthetics. These treatments may employ interbody implants. Thisdisclosure describes an improvement over these prior art technologies.

SUMMARY

Accordingly, an expandable interbody implant system and method aredisclosed. In one embodiment, the system includes a device to spaceapart vertebral members. The device comprises a first endplatecomprising a first engagement surface and first and second extensionsthat each extend away from the first engagement surface. The firstextension comprises a first ramp and the second extension comprises afirst slot. A second endplate comprises a second engagement surface andthird and fourth extensions that each extend away from the secondengagement surface. The third extension comprises a second ramp and thefourth extension comprises a second slot. A wedge is positioned betweenthe endplates. The wedge comprises an upper surface having a firstinclined portion that slidably engages the first ramp and a lowersurface having a second inclined portion that slidably engages thesecond ramp. The wedge comprises first and second apertures. A first pinextends through the first aperture and the first slot. A second pinextends through the second aperture and the second slot. The wedge ismovable relative to the endplates to move the device between a firstconfiguration having a first height between the engagement surfaces anda second configuration having an increased second height between theengagement surfaces.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a perspective view of one embodiment of an implant of a systemin accordance with the principles of the present disclosure;

FIG. 2 is a perspective view of the implant shown in FIG. 1;

FIG. 3 is a perspective view of the implant shown in FIG. 1;

FIG. 4 is a perspective view of the implant shown in FIG. 1;

FIG. 5 is a top, perspective view of a component of the implant shown inFIG. 1;

FIG. 6 is a bottom view of a component of the implant shown in FIG. 1;

FIG. 7 is a top, perspective view of a component of the implant shown inFIG. 1;

FIG. 8 is a top view of a component of the implant shown in FIG. 1;

FIG. 9 is a top, perspective view of a component of the implant shown inFIG. 1;

FIG. 10 is a top view of a component of the implant shown in FIG. 1;

FIG. 10A is an end, perspective view of a component of the implant shownin FIG. 1;

FIG. 11 is a top, perspective view of a component of the implant shownin FIG. 1;

FIG. 12 is a top view of a component of the implant shown in FIG. 1;

FIG. 13 is a top, perspective view of a component of the implant shownin FIG. 1;

FIG. 14 is a bottom, perspective view of a component of the implantshown in FIG. 1;

FIG. 15 is a side view of a component of the implant shown in FIG. 1;

FIG. 16 is a top, perspective view of components of the implant shown inFIG. 1;

FIG. 17 is a top, perspective view of components of the implant shown inFIG. 1;

FIG. 18 is a top, perspective view of components of the implant shown inFIG. 1;

FIG. 19 is a top, perspective view of components of the implant shown inFIG. 1;

FIG. 20 is a top, perspective view of components of the implant shown inFIG. 1;

FIG. 21 is a top, perspective view of components of the implant shown inFIG. 1;

FIG. 22 is a top, perspective view of components of the implant shown inFIG. 1;

FIG. 23 is a top, perspective view of components of the implant shown inFIG. 1;

FIG. 24 is a top view of the implant shown in FIG. 1; and

FIG. 25 is a top view of the implant shown in FIG. 1.

DETAILED DESCRIPTION

The exemplary embodiments of an expandable interbody implant system andrelated methods of use disclosed herein are discussed in terms ofmedical devices for the treatment of musculoskeletal disorders and moreparticularly, in terms of an expandable interbody implant system andrelated methods for treating a vertebral column. It is envisioned thatthe implant system may provide, for example, fusion, decompression,restoration of sagittal balance and resistance of subsidence intotissue, such as, for example, surfaces of vertebral endplates. It isfurther envisioned that the system includes an interbody implant thatexpands after insertion into an intervertebral disc space and hasseveral features, such as, for example, facile insertion into theintervertebral disc space such that less bone removal is necessaryduring a surgical procedure, decompression of nerve roots, and expansionto restore sagittal balance such that more expansion is provided on ananterior side relative to a posterior side in for example, a lumbarapplication. In some embodiments, the interbody implant can be insertedinto the intervertebral disc space using a passive (e.g., non-steerable)or active (e.g., steerable) inserter. In some embodiments, the interbodyimplant is configured to be inserted at about a 15 degree angle and canbe articulated about 85 degrees to about 100 degrees. This arrangementallows for continuous angulation, which allows implant deployment at anyangle from about 15 through about 85-100 degrees. That is, the interbodyimplant is configured to be inserted at a starting angle of about 15degrees with about 85-100 degrees of additional angulation. In someembodiments, articulation is achieved through the use of a pivot that issecured to a frame of the implant. In some embodiments, the pivot issecured to the frame using pivot plugs. In some embodiments, theinterbody implant can be deployed at any insertion angle. In someembodiments, the interbody implant can be deployed at any angle fromabout 15 to about 85-90 degrees. In some embodiments, the expandableinterbody implant has a 32 millimeter (mm) by 13.5 mm footprint. In someembodiments, the expandable interbody implant has a maximum insertionfootprint of about 13.5 mm at 15 degrees.

In some embodiments, the expandable interbody implant has an undeployedheight and can be expanded to a deployed height. In some embodiments,the deployed height is less than twice the undeployed height. In someembodiments, the deployed height is twice the undeployed height. In someembodiments, the deployed height is greater than twice the undeployedheight. In some embodiments, the expandable interbody implant has anundeployed height of about 7 mm and can be expanded to a deployed heightof about 14 mm. In some embodiments, the expandable interbody implanthas an undeployed height of about 8 mm and can be expanded to a deployedheight of about 16 mm. In some embodiments, the expandable interbodyimplant has an undeployed height of about 9 mm and can be expanded to adeployed height of about 18 mm. In some embodiments, the expandableinterbody implant has an undeployed height of about 10 mm and can beexpanded to a deployed height of about 20 mm. In some embodiments, theexpandable interbody implant is deployed using a drive screw to move theimplant from the undeployed height to the deployed height. The drivescrew threads into the pivot discussed herein. In some embodiments, thedrive screw comprises a ball tip that is positioned in a circular orsemi-circular trough in a wedge of the implant, wherein unscrewing theball tipped screw retracts the wedge and undeploys the implant. In someembodiments, the expandable interbody implant may be incrementallydeployed from the undeployed height to the deployed height.

In some embodiments, the expandable interbody implant includes implantendplates, such as, for example, upper and lower implant endplates eachhaving ramps that engage ramps (inclined portions) of the wedge. Thatis, each of the implant endplates include multiple ramps. The wedgeincludes an upper surface with multiple ramps that engage the ramps ofthe upper endplate and a lower surface with multiple ramps that engagethe ramps of the lower endplate. The wedge moves relative to theendplates to move the ramps of the endplates along the ramps of thewedge to move the implant from the undeployed height to the deployedheight. As the wedge moves away from the pivot, endplate deployment isachieved. The ramps are staggered such that opposing ramps are notaligned or mirrored. The relative position of the implant endplates withrespect to the pivot is maintained by the frame. In some embodiments,the ramps of the implant endplate reside on the ramps of the wedge whenthe implant is fully deployed. In some embodiments, the ramps haveasymmetrical geometry to allow the endplates to be driven into aparallel relationship. In some embodiments, the ramps have asymmetricalgeometry to allow the endplates to be driven into a non-parallelrelationship (kyphosis or lordosis). In some embodiments, the ramps haveasymmetrical geometry to allow the endplates to simultaneously correctsagittal and coronal imbalance while restoring interbody height.

In some embodiments, the expandable interbody implant is kidney shapedand defines a curve of radii X. The wedge travels along radii X as theimplant moves between the undeployed and deployed heights. In someembodiments, all ramps, inclined portions, slots and other featuresconverge to the center of radii X in order to function, while avoidingbinding. In some embodiments, the radii can be infinity and the implantis a straight implant. In some embodiments, the expandable interbodyimplant is rectangular, bullet-shaped, lordotic or kyphotic-shaped.

In some embodiments, the expandable interbody implant system is employedwith a posterior approach to the intervertebral disc space. In someembodiments, the expandable interbody implant has a titaniumconstruction. In some embodiments, the expandable interbody implant isclosable. In some embodiments, the expandable interbody implant has athru design that defines a graft pocket configured for disposal of abone graft, for example. In some embodiments, the expandable interbodyimplant has multiple windows for entry of graft material into a cagedefined by the implant. In some embodiments, the expandable interbodyimplant has textured upper and lower surfaces for improved gripping ofvertebral surfaces.

It is envisioned that the expandable interbody implant and methods ofuse disclosed herein can be employed to obtain fusion of vertebraethrough a minimally invasive or percutaneous technique. In oneembodiment, the disclosed expandable interbody implant and methods ofuse can provide improved spinal treatment with a device that is made toexpand vertically to create lordosis in vertebrae. It is contemplatedthat the expandable interbody implant and methods of use disclosedherein provide a cavity of relatively large volume for post-packing ofat least one agent, for example, bone graft.

It is also envisioned that the present disclosure may be employed totreat spinal disorders such as, for example, degenerative disc disease,disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosisand other curvature abnormalities, kyphosis, tumor and fractures. It iscontemplated that the present disclosure may be employed with otherosteal and bone related applications, including those associated withdiagnostics and therapeutics. It is further contemplated that thedisclosed expandable interbody implant may be alternatively employed ina surgical treatment with a patient in a prone or supine position,and/or employ various surgical approaches to the spine, includinganterior, posterior, posterior mid-line, medial, lateral,postero-lateral, and/or antero-lateral approaches, and in other bodyregions. The expandable interbody implant of the present disclosure mayalso be alternatively employed with procedures for treating the lumbar,cervical, thoracic and pelvic regions of a spinal column. The expandableinterbody implant and methods of the present disclosure may also be usedon animals, bone models and other non-living substrates, such as, forexample, in training, testing and demonstration.

The present disclosure may be understood more readily by reference tothe following detailed description of the disclosure taken in connectionwith the accompanying drawing figures, which form a part of thisdisclosure. It is to be understood that this disclosure is not limitedto the specific devices, methods, conditions or parameters describedand/or shown herein, and that the terminology used herein is for thepurpose of describing particular embodiments by way of example only andis not intended to be limiting of the claimed disclosure. Also, as usedin the specification and including the appended claims, the singularforms “a,” “an,” and “the” include the plural, and reference to aparticular numerical value includes at least that particular value,unless the context clearly dictates otherwise. Ranges may be expressedherein as from “about” or “approximately” one particular value and/or to“about” or “approximately” another particular value. When such a rangeis expressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment. It isalso understood that all spatial references, such as, for example,horizontal, vertical, top, upper, lower, bottom, outer, inner, terminal(denoting position or location), left and right, posterior, anterior,and the like, are for illustrative purposes only and can be variedwithin the scope of the disclosure. For example, the references“superior” and “inferior” are relative and used only in the context tothe other, and are not necessarily “upper” and “lower”.

Further, as used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient in an effort to alleviate signs or symptoms of the disease orcondition. Alleviation can occur prior to signs or symptoms of thedisease or condition appearing, as well as after their appearance. Thus,treating or treatment includes preventing or prevention of disease orundesirable condition (for example, preventing the disease fromoccurring in a patient, who may be predisposed to the disease but hasnot yet been diagnosed as having it). In addition, treating or treatmentdoes not require complete alleviation of signs or symptoms, does notrequire a cure, and specifically includes procedures that have only amarginal effect on the patient. Treatment can include inhibiting thedisease, for example, arresting its development, or relieving thedisease, for example, causing regression of the disease. For example,treatment can include reducing acute or chronic inflammation;alleviating pain and mitigating and inducing re-growth of new ligament,bone and other tissues; as an adjunct in surgery; and/or any repairprocedure. Also, as used in the specification and including the appendedclaims, the term “tissue” includes soft tissue, ligaments, tendons,cartilage and/or bone unless specifically referred to otherwise.

The following discussion includes a description of an expandableinterbody implant and related methods of employing the expandableinterbody implant in accordance with the principles of the presentdisclosure. Alternate embodiments are also disclosed. Reference will nowbe made in detail to the exemplary embodiments of the presentdisclosure, which are illustrated in the accompanying figures. Turningnow to FIGS. 1-25, there are illustrated components of an interbodyimplant system including an intervertebral implant 20 in accordance withthe principles of the present disclosure.

The components of the system can be fabricated from biologicallyacceptable materials suitable for medical applications, includingmetals, synthetic polymers, ceramics and bone material and/or theircomposites, depending on the particular application and/or preference ofa medical practitioner. For example, the components of the system,individually or collectively, can be fabricated from materials such asstainless steel alloys, commercially pure titanium, titanium alloys,Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys,stainless steel alloys, superelastic metallic alloys (for example,Nitinol, super elasto-plastic metals, such as GUM METAL® manufactured byToyota Material Incorporated of Japan), ceramics and composites thereofsuch as calcium phosphate (for example, SKELITE™ manufactured byBiologix Inc.), thermoplastics such as polyaryl ether ketone (PAEK)including polyether ether ketone (PEEK), polyether ketone ketone (PEKK)and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO₄ polymericrubbers, polyethylene terephthalate (PET), fabric, silicone,polyurethane, silicone-polyurethane copolymers, polymeric rubbers,polyolefin rubbers, hydrogels, semi-rigid and rigid materials,elastomers, rubbers, thermoplastic elastomers, thermoset elastomers,elastomeric composites, rigid polymers including polyphenylene,polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone materialincluding autograft, allograft, xenograft or transgenic cortical and/orcorticocancellous bone, and tissue growth or differentiation factors,partially resorbable materials, such as, for example, composites ofmetals and calcium-based ceramics, composites of PEEK and calcium basedceramics, composites of PEEK with resorbable polymers, totallyresorbable materials, such as, for example, calcium based ceramics suchas calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite(HA)-TCP, calcium sulfate, or other resorbable polymers such aspolylactide, polyglycolide, polytyrosine carbonate, polycaprolactone andtheir combinations. Various components of the system may be fabricatedfrom material composites, including the above materials, to achievevarious desired characteristics such as strength, rigidity, elasticity,flexibility, compliance, biomechanical performance, durability andradiolucency or imaging preference. The components of the system,individually or collectively, may also be fabricated from aheterogeneous material such as a combination of two or more of theabove-described materials.

The system including intervertebral implant 20 can be employed as astabilization device in fusion and fixation procedures, for example, forpatients suffering from a spinal disorder to provide height restorationbetween vertebral bodies, decompression, restoration of sagittal balanceand/or resistance of subsidence into vertebral endplates. The componentsof the interbody implant system may be monolithically formed, integrallyconnected or include fastening elements and/or instruments, for example,as described herein.

Intervertebral implant 20 comprises an endplate 22, an opposite endplate24 and a wedge 26 positioned between endplates 22, 24. Wedge 26 andportions of endplates 22, 24 are positioned within a frame 28 of implant20, as discussed herein. Wedge 26 is configured to translate relative toendplates 22, 24 to move implant 20 between an undeployed or unexpandedconfiguration, shown in FIGS. 1 and 3, and a deployed or expandedconfiguration, shown in FIGS. 2 and 4, In some embodiments, implant 20is kidney-shaped and extends between an end 30 and an opposite end 32along a radius, such as, for example an arc X, as shown in FIGS. 1 and3. As such, a side 34 of implant 20 is convexly curved from end 30 toend 32 and an opposite side 36 of implant 20 is concavely curved fromend 30 to end 32. In some embodiments, arc X has a continuous radius ofcurvature. In some embodiments, arc X has a variable radius ofcurvature. In some embodiments, implant 20 is square, rectangular, oval,bullet-shaped, lordotic or kyphotic-shaped. In some embodiments, implant20 is made from one or more of the materials discussed herein. In someembodiments, implant 20 is made from a metal, such as, for example,titanium. In some embodiments, implant 20 consists of titanium or PEEK.

Endplate 22 extends along arc X between an end 38 and an opposite end40, as shown in FIGS. 5 and 6. End 38 is positioned adjacent to end 30of implant 20 and end 40 is positioned adjacent to end 32 of implant 20,Endplate 22 is curved along arc X. As such, one side of endplate 22 isconvexly curved between ends 38, 40 and an opposite side of endplate 22is concavely curved between ends 38, 40. Endplate 22 comprises anengagement surface 42 configured to engage a first vertebra and an innersurface 44 opposite engagement surface 42. Inner surface 44 faces awayfrom engagement surface 42. Endplate 22 comprises extensions 46, 48, 50that extend from inner surface 44 such that extensions 46, 48, 50 eachextend away from engagement surface 42. Extension 46 includes anextension 46 a and an extension 46 b that is spaced apart from extension46 a by an opening 52 that extends through engagement surface 42 andinner surface 44. Extension 48 includes an extension 48 a and anextension 48 b that is spaced apart from extension 48 a such thatextensions 46 a, 46 b are positioned between extensions 48 a, 48 b.Extension 50 extends across opening 52 from one side of endplate 22 toan opposite side of endplate 22.

Extension 46 a includes a planar portion 54 a and a ramp 56 a thatextends from planar portion 54 a. Extension 46 b includes a planarportion 54 b and a ramp 56 b that extends from planar portion 54 b.Ramps 56 a, 56 b are configured to slidably engage inclined portions ofwedge 26 to move implant 20 between the unexpanded configuration shownin FIGS. 1 and 3 and the expanded configuration shown in FIGS. 2 and 4,as discussed herein. In some embodiments, planar portion 54 a extendsparallel or substantially parallel to planar portion 54 b. In someembodiments, planar portion 54 a and planar portion 54 b have the samepitch or a similar pitch, but different diameters such that planarportion 54 b has a larger radius of curvature than planar portion 54 aalong arc X. As such, planar portion 54 b has a length that is greaterthan that of planar portion 54 a. In some embodiments, planar portions54 a, 54 b each extend parallel to engagement surface 42 and ramps 56 a,56 b each extend transverse to engagement surface 42. In someembodiments, ramps 56 a, 56 b extend at an acute angle relative toengagement surface 42. In that endplate 22 is curved along arc X, planarportion 54 b has a maximum length that is greater than a maximum lengthof planar portion 54 a and ramp 56 b has a maximum length that isgreater than a maximum length of ramp 56 a. This allows engagementsurface 42 to remain parallel to an engagement surface of endplate 24 asimplant 20 moves between the unexpanded configuration and the expandedconfiguration, as discussed herein. In some embodiments, planar portion54 a, planar portion 54 b, ramp 56 a and/or ramp 56 b may be disposed atalternate orientations, relative to engagement surface 42, such as, forexample, transverse, perpendicular and/or other angular orientationssuch as acute or obtuse, co-axial and/or may be offset or staggered.

Extension 48 a includes a slot 58 a and extension 48 b includes a slot58 b. Slots 58 a, 58 b each extend transverse to engagement surface 42.In some embodiments, slot 58 a extends parallel to slot 58 b. In someembodiments, slots 58 a, 58 b each extend parallel to ramp 56 a and/orramp 56 b. Due to the curvature of endplate 22 along arc X, slot 58 bhas a maximum length that is greater than a maximum length of slot 58 a,which allows engagement surface 42 to remain parallel to the engagementsurface of endplate 24 as implant 20 moves between the unexpandedconfiguration and the expanded configuration, as discussed herein. Slots58 a, 58 b each have an oblong configuration. In some embodiments, slot58 a and/or slot 58 b can be variously shaped, such as, for example,oval, triangular, square, polygonal, irregular, uniform, non-uniform,offset, staggered, undulating, arcuate, variable and/or tapered. In someembodiments, slot 58 a and/or slot 58 b may be disposed at alternateorientations, relative to engagement surface 42, ramp 56 a and/or ramp56 b, such as, for example, transverse, perpendicular and/or otherangular orientations such as acute or obtuse, co-axial and/or may beoffset or staggered.

Extension 50 includes a planar portion 60 and a ramp 62 that extendsfrom planar portion 60. Ramp 62 is configured to slidably engageinclined portions of wedge 26 to move implant 20 between the unexpandedconfiguration shown in FIGS. 1 and 3 and the expanded configurationshown in FIGS. 2 and 4, as discussed herein. Planar portion 60 extendsparallel to engagement surface 42, planar portion 54 a and/or planarportion 54 b. Ramp 62 extends parallel to ramp 56 a and/or ramp 56 b. Insome embodiments, planar portion 60 extends parallel to engagementsurface 42 and ramp 62 extends transverse to engagement surface 42. Insome embodiments, ramp 62 extends at an acute angle relative toengagement surface 42. In some embodiments, planar portion 60 and/orramp 62 may be disposed at alternate orientations, relative toengagement surface 42, planar portion 54 a, planar portion 54 b, ramp 56a and/or ramp 56 b, such as, for example, transverse, perpendicularand/or other angular orientations such as acute or obtuse, co-axialand/or may be offset or staggered.

Endplate 24 extends along arc X between an end 64 and an opposite end66, as shown in FIGS. 7 and 8. End 64 is positioned adjacent to end 30of implant 20 and end 66 is positioned adjacent to end 32 of implant 20.Endplate 24 is curved along arc X. As such, one side of endplate 24 isconvexly curved between ends 64, 66 and an opposite side of endplate 24is concavely curved between ends 64, 66. Endplate 24 comprises anengagement surface 68 configured to engage a second vertebra and aninner surface 70 opposite engagement surface 68. Inner surface 70 facesaway from engagement surface 68. Endplate 24 comprises extensions 72,74, 76, 78 that extend from inner surface 70 such that extensions 72,74, 76, 78 each extend away from engagement surface 68. Extension 72includes an extension 72 a and an extension 72 b that is spaced apartfrom extension 72 a by an opening 80 that extends through engagementsurface 68 and inner surface 70. Extension 74 includes an extension 74 aand an extension 74 b that is spaced apart from extension 74 a such thatextensions 72 a, 72 b are positioned between extensions 74 a, 74 b.Extension 76 includes an extension 76 a and an extension 76 b that isspaced apart from extension 76 a by opening 80. Extension 78 ispositioned adjacent to extension 76 such that extension 76 b ispositioned between extension 76 a and extension 78.

Extension 72 a includes a ramp 82 a and extension 72 b includes a ramp82 b that is joined to ramp 82 a by a planar portion 84 of extension 72.Ramps 82 a, 82 b are configured to slidably engage inclined portions ofwedge 26 to move implant 20 between the unexpanded configuration shownin FIGS. 1 and 3 and the expanded configuration shown in FIGS. 2 and 4,as discussed herein. Planar portion 84 extends parallel to engagementsurface 68. Ramp 82 a extends parallel to ramp 82 b. In someembodiments, planar portion 84 extends parallel to engagement surface 68and ramps 82 a, 82 b each extend transverse to engagement surface 68. Insome embodiments, ramps 82 a, 82 b extend at an acute angle relative toengagement surface 68. In that endplate 24 is curved along arc X, ramp82 b has a maximum length that is greater than a maximum length of ramp82 a. This allows engagement surface 68 to remain parallel to engagementsurface 42 of endplate 22 as implant 20 moves between the unexpandedconfiguration and the expanded configuration, as discussed herein. Insome embodiments, planar portion 84, ramp 82 a and/or ramp 82 b may bedisposed at alternate orientations, relative to engagement surface 68,such as, for example, transverse, perpendicular and/or other angularorientations such as acute or obtuse, co-axial and/or may be offset orstaggered.

Extension 74 a includes a slot 86 a and extension 74 b includes a slot86 b. Slots 86 a, 86 b each extend transverse to engagement surface 68.In some embodiments, slot 86 a extends parallel to slot 86 b. In someembodiments, slots 86 a, 86 b each extend parallel to ramp 82 a and/orramp 82 b. Due to the curvature of endplate 24 along arc X, slot 86 bhas a maximum length that is greater than a maximum length of slot 86 a,which allows engagement surface 68 to remain parallel to engagementsurface 42 of endplate 22 as implant 20 moves between the unexpandedconfiguration and the expanded configuration, as discussed herein. Slots86 a, 86 b each have an oblong configuration. In some embodiments, slot86 a and/or slot 86 b can be variously shaped, such as, for example,oval, triangular, square, polygonal, irregular, uniform, non-uniform,offset, staggered, undulating, arcuate, variable and/or tapered. In someembodiments, slot 86 a and/or slot 86 b may be disposed at alternateorientations, relative to engagement surface 68, ramp 82 a and/or ramp82 b, such as, for example, transverse, perpendicular and/or otherangular orientations such as acute or obtuse, co-axial and/or may beoffset or staggered.

Extension 76 a includes a planar portion 88 a and a ramp 90 a thatextends from planar portion 88 a, Extension 76 b includes a planarportion 88 b and a ramp 90 b that extends from planar portion 88 b.Ramps 90 a, 90 b are configured to slidably engage inclined portions ofwedge 26 to move implant 20 between the unexpanded configuration shownin FIGS. 1 and 3 and the expanded configuration shown in FIGS. 2 and 4,as discussed herein. Planar portion 88 a extends parallel to planarportion 88 b. Ramp 90 a extends parallel to ramp 90 b. In someembodiments, planar portions 88 a, 88 b each extend parallel toengagement surface 68 and ramps 90 a, 90 b each extend transverse toengagement surface 68. In some embodiments, ramps 90 a, 90 b extend atan acute angle relative to engagement surface 68. In that endplate 24 iscurved along arc X, planar portion 88 b has a maximum length that isgreater than a maximum length of planar portion 88 a and ramp 90 b has amaximum length that is greater than a maximum length of ramp 90 a. Thisallows engagement surface 68 to remain parallel to engagement surface 42of endplate 22 as implant 20 moves between the unexpanded configurationand the expanded configuration, as discussed herein. In someembodiments, ramp 90 a and/or ramp 90 b extends parallel to ramp 82 aand/or ramp 82 b. In some embodiments, planar portion 88 a, planarportion 88 b, ramp 90 a and/or ramp 90 b may be disposed at alternateorientations, relative to engagement surface 68, such as, for example,transverse, perpendicular and/or other angular orientations such asacute or obtuse, co-axial and/or may be offset or staggered.

Extension 78 includes a slot 92 that extends transverse to engagementsurface 68. In some embodiments, slot 92 extends parallel to ramp 90 aand/or ramp 90 b. Slot 92 has an oblong configuration. In someembodiments, slot 92 can be variously shaped, such as, for example,oval, triangular, square, polygonal, irregular, uniform, non-uniform,offset, staggered, undulating, arcuate, variable and/or tapered. In someembodiments, slot 92 extends parallel to slot 86 a and/or slot 86 b. Insome embodiments, slot 92 may be disposed at alternate orientations,relative to engagement surface 68, ramp 90 a and/or ramp 90 b, such as,for example, transverse, perpendicular and/or other angular orientationssuch as acute or obtuse, co-axial and/or may be offset or staggered.

Wedge 26 extends along arc X between an end 94 and an opposite end 96,as shown in FIGS. 9 and 10. End 94 is positioned adjacent to end 30 ofimplant 20 and end 96 is positioned adjacent to end 32 of implant 20,Wedge 26 is curved along arc X. As such, one side of wedge 26 isconvexly curved between ends 94, 96 and an opposite side of wedge 26 isconcavely curved between ends 94, 96. Wedge 26 includes a wall 98 havingan upper surface 100 and a lower surface 102 opposite upper surface 100.

Upper surface 100 includes spaced apart vertical portions 104 a, 104 b,horizontal portions 106 a, 106 b, 106 c, 106 d and inclined portions 108a, 108 b. Vertical portion 104 a is positioned between horizontalportion 106 a and horizontal portion 106 b. Inclined portion 108 a ispositioned between horizontal portion 106 b and horizontal portion 106c. Inclined portion 108 b is positioned between vertical portion 104 band horizontal portion 106 d. Inclined portion 108 a is configured toslidably engage ramp 56 b and inclined portion 108 b is configured toslidably engage ramp 62 as implant 20 moves between the unexpandedconfiguration and the expanded configuration, as discussed herein.Vertical portions 104 a, 104 b extend parallel to one another.Horizontal portions 106 a, 106 b, 106 c, 106 d extend parallel to oneanother. Horizontal portions 106 a, 106 b, 106 c, 106 d extendtransverse to vertical portions 104 a, 104 b. In some embodiments,horizontal portions 106 a, 106 b, 106 c. 106 d extend perpendicular tovertical portions 104 a, 104 b, Inclined portions 108 a, 108 b eachextend transverse to vertical portions 104 a, 104 b and transverse tohorizontal portions 106 a, 106 b, 106 c, 106 d. In some embodiments,inclined portions 108 a, 108 b extend parallel to one another. In someembodiments, inclined portion 108 a extends transverse to inclinedportion 108 b.

Upper surface 100 includes spaced apart vertical portions 110 a, 110 b,horizontal portions 112 a, 112 b and inclined portions 114 a, 114 b.Vertical portion 110 a is positioned between horizontal portion 106 aand horizontal portion 112 a. Inclined portion 114 a is positionedbetween horizontal portion 112 a and horizontal portion 112 b. Inclinedportion 114 b is positioned between vertical portion 110 b andhorizontal portion 106 d. Inclined portion 114 a is configured toslidably engage ramp 56 a and inclined portion 114 b is configured toslidably engage ramp 62 as implant 20 moves between the unexpandedconfiguration and the expanded configuration, as discussed herein.Vertical portions 110 a, 110 b extend parallel to one another. In someembodiments, vertical portions 110 a, 110 b extend parallel to verticalportions 104 a, 104 b. Horizontal portions 112 a, 112 b extend parallelto one another. In some embodiments, horizontal portions 112 a, 112 bextend parallel to horizontal portions 106 a, 106 b, 106 c, 106 d.Horizontal portions 112 a, 112 b extend transverse to vertical portions110 a, 110 b. In some embodiments, horizontal portions 112 a, 112 bextend perpendicular to vertical portions 110 a, 110 b. Inclinedportions 114 a, 114 b each extend transverse to vertical portions 110 a,110 b and transverse to horizontal portions 112 a, 112 b. In someembodiments, inclined portion 114 a extends parallel to inclined portion108 a and inclined portion 114 b extends parallel to inclined portion108 b. In some embodiments, inclined portions 114 a, 114 b extendparallel to one another. In some embodiments, inclined portion 114 aextends transverse to inclined portion 114 b.

In that wedge 26 is curved along arc X, inclined portion 108 a has amaximum length that is greater than a maximum length of inclined portion114 a and inclined portion 108 b has a maximum length that is greaterthan a maximum length of inclined portion 114 b. Likewise, horizontalportion 106 b has a maximum length that is greater than a maximum lengthof horizontal portion 112 a and horizontal portion 106 c has a maximumlength that is greater than a maximum length of horizontal portion 112b. This allows engagement surface 68 to remain parallel to engagementsurface 42 of endplate 22 as implant 20 moves between the unexpandedconfiguration and the expanded configuration, as discussed herein.

Lower surface 102 includes spaced apart inclined portions 116 a, 116 b,horizontal portions 118 a, 118 b, 118 c and a vertical portion 120.Horizontal portion 118 a is positioned between inclined portion 116 aand vertical portion 120. Horizontal portion 118 b is positioned betweenvertical portion 120 and inclined portion 116 b. Inclined portion 116 bis positioned between horizontal portion 118 b and horizontal portion118 c. Inclined portion 116 a is configured to slidably engage ramp 82 band inclined portion 116 b is configured to slidably engage ramp 90 b asimplant 20 moves between the unexpanded configuration and the expandedconfiguration, as discussed herein. Vertical portion 120 extendsparallel to vertical portions 104 a, 104 b and/or vertical portions 110a, 110 b. Horizontal portions 118 a, 118 b, 118 c extend parallel to oneanother. In some embodiments, horizontal portions 118 a, 118 b, 118 cextend parallel to horizontal portions 106 a, 106 b, 106 c, 106 d and/orhorizontal portions 112 a, 112 b. Horizontal portions 118 a, 118 b, 118c extend transverse to vertical portion 120. In some embodiments,horizontal portions 118 a, 118 b, 118 c extend perpendicular to verticalportion 120. Inclined portions 116 a, 116 b each extend transverse tovertical portion 120 and transverse to horizontal portions 118 a, 118 b,118 c. In some embodiments, inclined portions 116 a, 116 b extendparallel to one another. In some embodiments, inclined portion 116 aextends transverse to inclined portion 116 b.

Lower surface 102 includes spaced apart inclined portions 122 a, 122 b,horizontal portions 124 a, 124 b, 124 c and a vertical portion 126.Horizontal portion 124 a is positioned between inclined portion 122 aand vertical portion 126. Horizontal portion 124 b is positioned betweenvertical portion 126 and inclined portion 122 b. Inclined portion 122 bis positioned between horizontal portion 124 b and horizontal portion124 c. Inclined portion 122 a is configured to slidably engage ramp 82 aand inclined portion 122 b is configured to slidably engage ramp 90 a asimplant 20 moves between the unexpanded configuration and the expandedconfiguration, as discussed herein. Vertical portion 126 extendsparallel to vertical portion 120, vertical portions 104 a, 104 b and/orvertical portions 110 a, 110 b. Horizontal portions 124 a, 124 b, 124 cextend parallel to one another. In some embodiments, horizontal portions124 a, 124 b, 124 c extend parallel to horizontal portions 118 a, 118 b,118 c, horizontal portions 106 a, 106 b, 106 c, 106 d and/or horizontalportions 112 a, 112 b. Horizontal portions 124 a, 124 b, 124 c extendtransverse to vertical portion 126. In some embodiments, horizontalportions 124 a, 124 b, 124 c extend perpendicular to vertical portion126. Inclined portions 122 a, 122 b each extend transverse to verticalportion 126 and transverse to horizontal portions 124 a, 124 b, 124 c.In some embodiments, inclined portions 122 a, 122 b extend parallel toone another. In some embodiments, inclined portion 122 a extendstransverse to inclined portion 122 b. In some embodiments, inclinedportion 122 a extends parallel to inclined portion 116 a and inclinedportion 122 b extends parallel to inclined portion 116 b.

In that wedge 26 is curved along arc X, inclined portion 116 a has amaximum length that is greater than a maximum length of inclined portion122 a and inclined portion 116 b has a maximum length that is greaterthan a maximum length of inclined portion 122 b. Likewise, horizontalportion 118 b has a maximum length that is greater than a maximum lengthof horizontal portion 124 b and horizontal portion 118 a has a maximumlength that is greater than a maximum length of horizontal portion 124a. This allows engagement surface 68 to remain parallel to engagementsurface 42 of endplate 22 as implant 20 moves between the unexpandedconfiguration and the expanded configuration, as discussed herein.

Wedge 26 includes a cavity 128. When implant 20 is assembled, cavity 128is in communication with openings 52, 80 such that a material, such as,for example, bone graft material, can be inserted through opening 52and/or opening 80 and into cavity 128. Cavity 128 separates horizontalportion 106 b from horizontal portion 112 a, inclined portion 108 a frominclined portion 114 a, horizontal portion 106 c from horizontal portion112 b, vertical portion 104 a from vertical portion 110 a, verticalportion 104 b from vertical portion 110 b and inclined portion 108 bfrom inclined portion 114 b. Cavity 128 also separates inclined portion116 a from inclined portion 122 a, horizontal portion 118 a fromhorizontal portion 124 a, vertical portion 120 from vertical portion126, horizontal portion 118 b from horizontal portion 124 b, inclinedportion 116 b from inclined portion 122 b and horizontal portion 118 cfrom horizontal portion 124 c.

Wedge 26 comprises a plurality of apertures that extend through wall 98.For example, wedge 26 comprises an aperture 130 a that extends throughwall 98 between horizontal portions 106 b, 118 a; an aperture 130 b thatextends through wall 98 between horizontal portions 112 a, 124 a; anaperture 130 c that extends through wall 98 between horizontal portions106 c, 118 b; an aperture 130 d that extends through wall 98 betweenhorizontal portions 112 b, 124 b, an aperture 130 e that extends throughwall 98 between inclined portion 108 b and horizontal portion 118 c; andan aperture 130 f that extends through wall 98 between inclined portion114 b and horizontal portion 124 c. Aperture 130 a is coaxial withaperture 130 b; aperture 130 c is coaxial with aperture 130 d; andaperture 130 e is coaxial with aperture 130 f. Upon assembly of implant20, apertures 130 a, 130 b are aligned with slots 86 a, 86 b of endplate24 such that a pin extends through apertures 130 a, 130 b and slots 86a, 86 b, as discussed herein; apertures 130 c, 130 d are aligned withslots 58 a, 58 b of endplate 22 such that a pin extends throughapertures 130 c, 130 d and slots 58 a, 58 b, as discussed herein; andapertures 130 e, 130 f are aligned with slot 92 of endplate 24 such thata pin extends through apertures 130 e, 130 f and slot 92, as discussedherein.

End 96 of wedge 26 comprises an enlarged end wall 132, as shown in FIG.10A. Wall 132 has a maximum width that is greater than a maximum widthof end 94 and/or wall 98. An inner surface of wall 132 defines anarcuate trough 134. Trough 134 is configured for disposal of an actuatorof implant 20, as discussed herein. In some embodiments trough 134 has acontinuous radius of curvature from a first end of trough 134 to asecond end of trough 134. In some embodiments trough 134 has a variableradius of curvature from the first end of trough 134 to the second endof trough 134.

Frame 28 extends between an end 136 and an opposite end 138, as shown inFIGS. 11 and 12. End 136 is positioned adjacent to end 30 of implant 20and end 138 is positioned adjacent to end 32 of implant 20. Frame 28 iscurved along arc X between end 136 and end 138. Frame 28 includes a wall140 having an inner surface that defines an interior cavity 142. Wedge26 and at least a portion of each of endplates 22, 24 are positionedwithin interior cavity 142. End 138 of frame 28 includes an upper wall143 and a lower wall 144. Upper wall 143 is spaced apart from lower wall144 to define a recess 148 between upper wall 143 and lower wall 144.Recess 148 is configured for disposal of a pivot 150, as discussedherein. Upper wall 143 includes an opening 152 that is aligned with anopening 154 in lower wall 144. Openings 152, 154 are each configured fordisposal of a pivot plug to couple pivot 150 to frame 28, as discussedherein. In some embodiments, opening 152 is coaxial with opening 154.

Pivot 150 includes an upper surface 156 and a lower surface 158 oppositeupper surface 156, as shown in FIGS. 13 and 14. Pivot 150 includes aring 160 that extends from upper surface 156 and a ring 162 that extendsfrom lower surface 158. Rings 160, 162 are aligned with one another suchthat ring 160 is coaxial with ring 162. Rings 160, 162 each have aninner diameter that is equivalent to opening 152 and/or opening 154.When pivot 150 is positioned within recess 148, ring 160 is aligned withopening 152 such that a plug, such as, for example, a pivot plug 164extends through opening 152 and into ring 160, and ring 162 is alignedwith opening 154 such that a plug, such as, for example, a pivot plug166 extends through opening 154 and into ring 162 to couple pivot 150 toframe 28, as discussed herein.

Pivot 150 includes a threaded passageway 168 and a threaded passageway170 that are spaced apart from passageway 168 by a wall 172. Passageways168, 170 are each configured for disposal of an insertion tool and/or anactuator 174 of implant 20. The insertion tool may be used to insertimplant 20 between adjacent vertebrae, for example. Actuator 174includes a threaded shaft 176 and a ball-shaped tip 178 attached toshaft 176, as shown in FIG. 15, for example. Tip 178 is positionedwithin trough 134 of wedge 26 and shaft 176 is positioned withinpassageway 168 or passageway 170 such that the threads on shaft 176engage threads of passageway 168 or threads of passageway 170. Rotationof shaft 176 within passageway 168 or passageway 170 causes actuator 174to translate axially relative to pivot 150 such that tip 178 pusheswedge 26 relative to endplates 22, 24 and frame 28 to move implant 20from the unexpanded configuration to the expanded configuration, asdiscussed herein. In some embodiments, shaft 176 includes a socket thatis configured to mate with a bit of a driver such that the bit of thedriver can be inserted within the socket to rotate actuator 174 relativeto pivot 150. In some embodiments, the socket may have a cruciform,Phillips, square, hexagonal, polygonal, star or hexalobe cross sectionalconfiguration. It is envisioned that the socket may have anyconfiguration that allows the tip of the driver to mate with the socketsuch that rotation of the driver rotates actuator 174.

Through holes and slots could be provided in the components described toallow injection of graft material from outside the interbody device intoopening 52, opening 80 and/or cavity 128 to promote fusion. The graftmaterial could be transported from outside the incision into opening 52,opening 80 and/or cavity 128, or could be loaded at some intermediaryholding chamber, possibly within the inserter midway into the incision,to then be injected or passed into opening 52, opening 80 and/or cavity128. One specific example might be providing a loading tube integral tothe actuator driver which would then flow into a central hole inactuator 174, then into the common cavity of endplate 22, endplate 24and wedge 26. It is conceived that the graft material would flow intothe common cavity, then ports provided in an outer wall of implant 20 toallow the graft to flow into the interbody space. Anchoring features mayalso be included to allow flow from outside implant 20 into the discspace directly, bypassing implant 20 altogether.

Implant 20 may be assembled by positioning wedge 26 through recess 148of frame 28 such that end 94 of wedge 26 is positioned within cavity 142of frame 28, as shown in FIG. 16. Wedge 26 is translated relative toframe 28 in the direction shown by arrow A in FIG. 17 such that end 94of wedge 26 is positioned within cavity 142 of frame 28 and wall 132 ofwedge 26 is positioned within recess 148 of frame 28 such that anarcuate cutout 180 of wedge 26 is aligned with openings 152, 154, asshown in FIG. 17. End 94 of wedge 26 is positioned entirely withincavity 142 such that end 94 is surrounded by wall 140 of frame 28.

Endplate 24 is coupled to frame 28 by positioning wall 140 of frame 28between extensions 72 a, 74 a of endplate 24, between extensions 72 b,74 b of endplate 24 and between extensions 76 b, 78 of endplate 24, asshown in FIG. 18. An axial surface 182 of extension 74 a engages aflange 184 of frame 28; an axial surface 186 of extension 74 b engages aflange 188 of frame 28; and an axial surface 190 of extension 78 engagesa flange 192 of frame 28. Endplate 24 is positioned relative to wedge 26such that inclined portion 116 a of wedge 26 engages ramp 82 b ofendplate 24, inclined portion 122 a of wedge 26 engages ramp 82 a ofendplate 24, horizontal portions 118 a, 124 a of wedge 26 engage innersurface 70 of endplate 24, horizontal portion 118 b of wedge 26 engagesplanar portion 88 b of endplate 24, horizontal portion 124 b of wedge 26engages planar portion 88 a of endplate 24, inclined portion 116 b ofwedge 26 engages ramp 90 b of endplate 24 and inclined portion 122 b ofwedge 26 engages ramp 90 a of endplate 24.

Endplate 22 is coupled to frame 28 by positioning wall 140 of frame 28between extensions 46 a, 48 a of endplate 22 and between extensions 46b, 48 b of endplate 22. Endplate 22 is positioned relative to endplate24 such that an axial surface 194 of extension 48 a engages an axialsurface 196 of extension 74 a and an opposite axial surface 198 ofextension 48 a engages a flange 200 of frame 28. Likewise, an axialsurface 202 of extension 48 b engages an axial surface 204 of extension74 b, and an opposite axial surface 206 of extension 48 b engages aflange 208 of frame 28. The configuration and engagement of axialsurfaces 182, 186, 190, 194, 196, 202, 204, 206 and flanges 184, 188,192, 200, 208 keys endplates 22, 24 with frame 28 such that endplate 22moves relative to frame 28 in the direction shown by arrow B in FIG. 19and endplate 24 moves relative to frame 28 in the direction shown byarrow C in FIG. 19 as implant 20 moves from the unexpanded configurationto the expanded configuration, as discussed herein, Endplate 22 iscoupled to wedge 26 such that planar portion 54 a of endplate 22 engageshorizontal portion 112 a, planar portion 54 b of endplate 22 engageshorizontal portion 106 b of wedge 26, ramp 56 a of endplate 22 engagesinclined portion 108 a of wedge 26, ramp 56 b of endplate 22 engagesinclined portion 114 a of wedge 26 and ramp 62 of endplate 22 engagesinclined portions 108 b, 114 b of wedge 26.

Actuator 174 is coupled to pivot 150 by inserting shaft 176 of actuator174 into one of passageways 168, 170 such that threads on shaft 176engage the threads of one of passageways 168, 170, as shown in FIG. 20.Tip 178 of actuator 174 is positioned within trough 134 of wedge 26 andpivot 150 is positioned within recess 148 of frame 28 such that ring 160of pivot 150 is aligned with opening 152 of frame 28, and ring 162 ofpivot 150 is aligned with opening 154 of frame 28, as shown in FIG. 21.

As shown in FIG. 22, pivot plug 164 is positioned through opening 152 offrame 28 and into ring 160 of pivot 150 and pivot plug 166 is positionedthrough opening 154 of frame 28 and into ring 162 of pivot 150 to couplepivot 150 to frame 28 such that pivot 150 is pivotable relative to frame28 about rings 160, 162 and/or pivot plugs 164, 166. A first pin 210 ispositioned through apertures 130 a, 130 b of wedge 26 and slots 86 a, 86b of endplate 24, as shown in FIG. 23. A second pin 212 is positionedthrough apertures 130 c, 130 d of wedge 26 and slots 58 a, 58 b ofendplate 22. A third pin 214 is positioned through apertures 130 e, 130f of wedge 26 and slot 92 of endplate 24.

In operation and use, the interbody implant system is employed with asurgical procedure, such as, a fusion treatment of a spine of a patientincluding vertebrae and body areas adjacent thereto, as discussedherein. The interbody implant system may also be employed with othersurgical procedures, such as, for example, discectomy, laminotomy,laminectomy, nerve-root retraction, foramenotomy, facetectomy,decompression, and spinal, nucleus or disc replacement.

For example, the interbody implant system can be employed with asurgical arthrodesis procedure, such as, for example, an interbodyfusion for treatment of an applicable condition or injury of an affectedsection of a spinal column and adjacent areas within a body, such as,for example, an intervertebral disc space between a first vertebra and asecond vertebra. It is contemplated that intervertebral implant 20 ofthe interbody implant system, described above, can be inserted withinthe intervertebral disc space to space apart articular joint surfaces,provide support and maximize stabilization of the vertebrae. It isfurther contemplated that intervertebral implant 20 provides heightrestoration between vertebral bodies, decompression, restoration ofsagittal balance and/or resistance of subsidence into vertebralendplates.

In use, to treat the affected section of the vertebrae, a medicalpractitioner obtains access to a surgical site including the vertebraein any appropriate manner, such as through incision and retraction oftissues. It is envisioned that the interbody implant system can be usedin any existing surgical method or technique including open surgery,mini-open surgery, minimally invasive surgery and percutaneous surgicalimplantation, whereby the vertebrae are accessed through a mini-incisionor sleeve that provides a protected passageway to the area. Once accessto the surgical site is obtained, the particular surgical procedure isperformed for treating the spine disorder. Intervertebral implant 20,described above, is then employed to augment the surgical treatment.Intervertebral implant 20 can be delivered or implanted as apre-assembled device or can be assembled in situ. Intervertebral implant20 can be completely or partially revised, removed or replaced in situ.It is contemplated that one or all of the components of the interbodyimplant system can be delivered to the surgical site via manualmanipulation and/or a free hand technique. It is further contemplatedthat intervertebral implant 20 may be inserted posteriorly, and thenmanipulated anteriorly and/or lateral and/or medial.

An incision is made in the body of a patient and a cutting instrumentcreates a surgical pathway for implantation of intervertebral implant 20within the patient's body. A guide instrument (not shown) is employed toinitially distract the first vertebra from the second vertebra. A sleeveor cannula is used to access the intervertebral disc space andfacilitate delivery and access for components of the interbody implantsystem. A preparation instrument can be inserted within the sleeve orcannula and disposed within the intervertebral disc space. Thepreparation instrument(s) can be employed to remove some or all of thedisc tissue including the disc nucleus and fluids, adjacent tissuesand/or bone, corticate, scrape and/or remove tissue from the surfaces ofendplates of the first and second vertebrae, as well as for aspirationand irrigation of the region according to the requirements of aparticular surgical application.

Intervertebral implant 20 is inserted into the patient with implant 20disposed in the unexpanded configuration shown in FIGS. 1 and 3. Implant20 is delivered along the surgical pathway using a substantiallyposterior approach to position implant 20 within the intervertebral discspace. In some embodiments, an end of an inserter is positioned withinpassageway 168 or passageway 170 of pivot 150 to couple implant 20 withthe inserter. In some embodiments, the end of the inserter includes athreaded tip that mates with threads of passageway 168 or passageway 170of pivot 150 to couple implant 20 with the inserter. The inserter isthen manipulated to deliver implant 20 into the prepared intervertebraldisc space, between the first vertebra and the second vertebra,according to the requirements of a particular surgical application.

Once implant 20 is positioned within the intervertebral disc space,implant 20 may be moved within the intervertebral disc space such thatimplant 20 is positioned within the intervertebral disc space at aselected angle by moving pivot 150 such that pivot 150 rotates relativeto endplates 22, 24, wedge 26 and frame 28. That is, implant 20 may berotated within the intervertebral disc space by articulating pivot 150to rotate pivot 150 relative to endplates 22, 24, wedge 26 and frame 28.In some embodiments, pivot 150 is rotated relative to endplates 22, 24,wedge 26 and frame 28 by manipulating the inserter. For example, theinserter may be used to pivot endplates 22, 24, wedge 26 and frame 28relative to pivot 150 from a first angle shown in FIG. 24 to a secondangle shown in FIG. 25. In some embodiments, the difference between thefirst and second angles is between about 15 degrees and about 85degrees. In some embodiments, pivot 150 is articulated relative toendplates 22, 24, wedge 26 and frame 28 such that implant 20 is disposedat a selected angle relative to the inserter before positioning implant20 within the intervertebral disc space. Implant 20 is then insertedinto the intervertebral disc space with implant 20 at the selected anglerelative to the inserter to position implant 20 at a selected anglewithin the intervertebral disc space. Once implant 20 is positionedwithin the intervertebral disc space with implant 20 at the selectedangle, the inserter can be uncoupled from implant 20 by rotating theinserter relative to pivot 150 such that the threaded tip of theinserter backs out of passageway 168 or passageway 170 of pivot 150.

Upon desired positioning of intervertebral implant 20 within theintervertebral disc space, the tip of the driver is inserted into asocket of shaft 176 of actuator 174 to mate features of the tip of thedriver with features of the socket of shaft 176 such that rotation ofthe driver rotates actuator 174 relative to pivot 150. Implant 20 isthen deployed within the intervertebral disc space to move implant 20from the unexpanded configuration, shown in FIGS. 1 and 3, to theexpanded configuration, shown in FIGS. 2 and 4. The driver is rotated ina first rotational direction, such as, for example, clockwise orcounterclockwise such that actuator 174 moves relative to pivot 150 inthe direction shown by arrow D in FIG. 1. As actuator 174 moves in thedirection shown by arrow D, tip 178 of actuator 174 pushes against theinner surface of end wall 132 that defines trough 134 of wedge 26 suchthat wedge 26 moves relative to endplates 22, 24 and frame 28 in thedirection shown by arrow D.

As wedge 26 moves relative to endplates 22, 24 and frame 28 in thedirection shown by arrow D, ramp 56 a of endplate 22 slides alonginclined portion 108 a of wedge 26, ramp 56 b of endplate 22 slidesalong inclined portion 114 a of wedge 26, ramp 62 of endplate 22 slidesalong inclined portions 108 b, 114 b of wedge 26, inclined portion 116 aof wedge 26 slides along ramp 82 b of endplate 24, inclined portion 122a of wedge 26 slides along ramp 82 a of endplate 24, inclined portion116 b of wedge 26 slides along ramp 90 b of endplate 24 and inclinedportion 122 b of wedge 26 slides along ramp 90 a of endplate 24. Thiscauses endplate 22 to move relative to frame 28 in the direction shownby arrow B in FIG. 19 and endplate 24 to move relative to frame 28 inthe direction shown by arrow C in FIG. 19, which moves implant 20 fromthe unexpanded configuration to the expanded configuration.

Pin 210 remains positioned within apertures 130 a, 130 b of wedge 26 andtranslates within slots 86 a, 86 b of endplate 24 as implant 20 movesfrom the unexpanded configuration to the expanded configuration. Thatis, pin 210 moves from one end of each of slots 86 a, 86 b to anopposite end of slots 86 a, 86 b as implant 20 moves from the unexpandedconfiguration to the expanded configuration. Pin 212 remains positionedwithin apertures 130 c, 130 d of wedge 26 and translates within slots 58a, 58 b of endplate 22 as implant 20 moves from the unexpandedconfiguration to the expanded configuration. That is, pin 212 moves fromone end of each of slots 58 a, 58 b to an opposite end of slots 58 a, 58b as implant 20 moves from the unexpanded configuration to the expandedconfiguration. Pin 214 remains positioned within apertures 130 e, 130 fof wedge 26 and translates within slot 92 of endplate 24 as implant 20moves from the unexpanded configuration to the expanded configuration.That is, pin 214 moves from one end of slot 92 to an opposite end ofslot 92 as implant 20 moves from the unexpanded configuration to theexpanded configuration.

Engagement surface 42 of endplate 22 is spaced apart a first distancefrom engagement surface 68 of endplate 24 when implant 20 is theunexpanded configuration. Engagement surface 42 is spaced apart anincreased second distance from engagement surface 68 when implant 20 isin the expanded configuration, shown in FIGS. 2 and 4. In someembodiments, the first distance is about 7 mm and the second distance isat least about 14 mm. In some embodiments, the first distance is about 8mm and the second distance is at least about 16 mm. In some embodiments,the first distance is about 9 mm and the second distance is at leastabout 18 mm.

As implant 20 moves from the unexpanded configuration to the expandedconfiguration, endplate 22 moves away from endplate 24 such thatengagement surface 42 of endplate 22 engages the first vertebra andengagement surface 68 of endplate 24 engages the second vertebra. Thatis, endplate 22 moves relative to frame 28 in the direction shown byarrow B in FIG. 19 and endplate 24 moves relative to frame 28 in thedirection shown by arrow C in FIG. 19. As endplates 22, 24 move in thedirections shown by arrows B and C, endplate 22 does not translateaxially relative to endplate 24 and/or frame 28 and endplate 24 does nottranslate axially relative to endplate 22 and/or frame 28. That is,endplate 22 does not translate relative to endplate 24 and/or frame 28in the direction shown by arrow E in FIG. 19 or the direction shown byarrow F in FIG. 19 as endplate 22 moves relative to frame 28 in thedirection shown by arrow B in FIG. 19. Likewise, endplate 24 does nottranslate relative to endplate 22 and/or frame 28 in the direction shownby arrow E in FIG. 19 or the direction shown by arrow F in FIG. 19 asendplate 24 moves relative to frame 28 in the direction shown by arrow Cin FIG. 19.

Endplates 22, 24 push against the vertebrae to move the first vertebraaway from the second vertebra and to increase the size of theintervertebral disc space. It is contemplated that in the deployed orexpanded configuration, intervertebral implant 20 provides heightrestoration between the first vertebra and the second vertebra,decompression, restoration of sagittal balance and resistance ofsubsidence into the endplates of the vertebrae. Implant 20 may be keptin the expanded configuration to maintain the increased size of theintervertebral disc space. In some embodiments, a material, such as, forexample, bone graft is positioned within cavity 128 of wedge 26 topromote bone growth to fuse the first vertebra with the second vertebra.In some embodiments, the material is inserted through opening 52 ofendplate 22 and into cavity 128. In some embodiments, the material isinserted through opening 80 of endplate 24 and into cavity 128. In someembodiments, the material is inserted into cavity 128 through anaperture or other opening in one or more of endplates 22, 24 and frame28, such as, for example, one or more of slots 58 a, 58 b, 86 a, 86 b,92.

In some embodiments, engagement surface 42 extends parallel toengagement surface 68 when implant 20 is in the expanded configuration.In some embodiments, engagement surface 42 extends transverse toengagement surface 68 when implant 20 is in the expanded configuration.It is envisioned that the ramps/inclined portions of endplates 22, 24and wedge 26 can be configured such that engagement surface 42 extendsat any angle between about 0 degrees and about 90 degrees relative toengagement surface 68 when implant 20 is in the expanded configuration.

In one embodiment, the bone graft can be a particulate material, whichmay include an osteoconductive material such as HA and/or anosteoinductive agent such as a bone morphogenic protein (BMP) to enhancebony fixation of intervertebral implant 20 with the adjacent vertebrae.It is contemplated that the bone graft may include therapeuticpolynucleotides or polypeptides. It is further contemplated that theagent and/or bone graft may include biocompatible materials, such as,for example, biocompatible metals and/or rigid polymers, such as,titanium elements, metal powders of titanium or titanium compositions,sterile bone materials, such as allograft or xenograft materials,synthetic bone materials such as coral and calcium compositions, such asHA, calcium phosphate and calcium sulfite, biologically active agents,for example, gradual release compositions such as by blending in abioresorbable polymer that releases the biologically active agent oragents in an appropriate time dependent fashion as the polymer degradeswithin the patient. Suitable biologically active agents include, forexample, BMP, Growth and Differentiation Factors proteins (GDF) andcytokines. Implant 20 can be made of radiolucent materials such aspolymers. Radiomarkers may be included for identification under x-ray,fluoroscopy, CT or other imaging techniques. It is envisioned that thebone graft may include one or a plurality of therapeutic agents and/orpharmacological agents for release, including sustained release, totreat, for example, pain, inflammation and degeneration.

It is envisioned that the components of the interbody implant system,which may include one or a plurality of intervertebral implants 20, canbe delivered to the surgical site via alternate approaches. In oneembodiment, intervertebral implant 20 is delivered through the surgicalpathway along a transforaminal lumbar interbody fusion approach into theintervertebral disc space and disposed in the deployed or expandedconfiguration. In one embodiment, a plurality of intervertebral implants20 are delivered through the surgical pathway along a posterior lumbarinterbody fusion approach into the intervertebral disc space anddisposed in the deployed or expanded configuration in a side by sideorientation.

In one embodiment, intervertebral implant 20 can be collapsed from theexpanded configuration to an alternate configuration between theexpanded configuration and the unexpanded configuration to collapseintervertebral implant 20 as may be desired to reposition with or removeintervertebral implant 20 from the intervertebral disc space. In oneembodiment, the interbody implant system includes a plurality ofintervertebral implants 20, which can be variously sized and configured,and/or oriented in a side by side engagement, spaced apart and/orstaggered.

Implant 20 may be moved from the expanded configuration to theunexpanded configuration by rotating the driver in a second rotationaldirection, such as, for example, clockwise or counterclockwise such thatactuator 174 moves relative to pivot 150 in the direction shown by arrowG in FIG. 1. As actuator 174 moves in the direction shown by arrow G,tip 178 of actuator 174 pulls end wall 132 of wedge 26 in the directionshown by arrow F in FIG. 19 such that wedge 26 moves relative toendplates 22, 24 and frame 28 in the direction shown by arrow F. Aswedge 26 moves relative to endplates 22, 24 and frame 28 in thedirection shown by arrow F, ramp 56 a of endplate 22 slides alonginclined portion 108 a of wedge 26, ramp 56 b of endplate 22 slidesalong inclined portion 114 a of wedge 26, ramp 62 of endplate 22 slidesalong inclined portions 108 b, 114 b of wedge 26, inclined portion 116 aof wedge 26 slides along ramp 82 b of endplate 24, inclined portion 122a of wedge 26 slides along ramp 82 a of endplate 24, inclined portion116 b of wedge 26 slides along ramp 90 b of endplate 24 and inclinedportion 122 b of wedge 26 slides along ramp 90 a of endplate 24. Thiscauses endplate 22 to move relative to frame 28 in the direction shownby arrow C in FIG. 19 and endplate 24 to move relative to frame 28 inthe direction shown by arrow B in FIG. 19, which moves implant 20 fromthe expanded configuration to the unexpanded configuration.

Pin 210 remains positioned within apertures 130 a, 130 b of wedge 26 andtranslates within slots 86 a, 86 b of endplate 24 as implant 20 movesfrom the expanded configuration to the unexpanded configuration. Thatis, pin 210 moves from one end of each of slots 86 a, 86 b to anopposite end of slots 86 a, 86 b as implant 20 moves from the expandedconfiguration to the unexpanded configuration. Pin 212 remainspositioned within apertures 130 c, 130 d of wedge 26 and translateswithin slots 58 a, 58 b of endplate 22 as implant 20 moves from theexpanded configuration to the unexpanded configuration. That is, pin 212moves from one end of each of slots 58 a, 58 b to an opposite end ofslots 58 a, 58 b as implant 20 moves from the expanded configuration tothe unexpanded configuration. Pin 214 remains positioned withinapertures 130 e, 130 f of wedge 26 and translates within slot 92 ofendplate 24 as implant 20 moves from the expanded configuration to theunexpanded configuration. That is, pin 214 moves from one end of slot 92to an opposite end of slot 92 as implant 20 moves from the expandedconfiguration to the unexpanded configuration. Once implant 20 is in theunexpanded configuration implant 20 can be moved within theintervertebral disc space and/or removed from the intervertebral discspace, as desired.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

What is claimed is:
 1. A device to space apart vertebral members, thedevice comprising: a first endplate comprising a first engagementsurface and a first ramp; a second endplate comprising a secondengagement surface and a second ramp; a wedge positioned between theendplates, the wedge comprising a first inclined portion that slidablyengages the first ramp and a second inclined portion that slidablyengages the second ramp; a frame having an interior cavity; and a pivotcoupled to the frame and an actuator that extends through the pivot,wherein the wedge is movable relative to the endplates to move thedevice between a first configuration having a first height between theengagement surfaces and a second configuration having an increasedsecond height between the engagement surfaces, wherein the ramps and thewedge being positioned within the interior cavity as the device movesbetween the first and second configurations, and wherein rotation of theactuator relative to the pivot translates the actuator such that thewedge moves relative to the endplates to move the device between thefirst and second configurations.
 2. The device recited in claim 1,further comprising a pin that is positioned in an aperture of the wedgeand translates within a slot of one of the endplates as the device movesbetween the first and second configurations.
 3. The device recited inclaim 2, wherein the pin is fixed to the wedge as the device movesbetween the first and second configurations.
 4. The device recited inclaim 1, further comprising a first pin that is positioned within afirst aperture of the wedge and translates within a first slot of thefirst endplate as the device moves between the first and secondconfigurations and a second pin that is positioned within a secondaperture of the wedge and translates within a second slot of the secondendplate as the device moves between the first and secondconfigurations.
 5. The device recited in claim 4, wherein the pins arefixed to the wedge as the device moves between the first and secondconfigurations.
 6. The device recited in claim 1, wherein the first rampextends transverse to the first engagement surface and the second rampextends transverse to the second engagement surface.
 7. The devicerecited in claim 1, wherein the first engagement surface extendsparallel to the second engagement surface when the device is in thefirst and second configurations.
 8. A device as recited in claim 1,wherein the actuator is a screw having a ball tip, the ball tip beingpositioned within an arcuate track in the wedge.
 9. The device recitedin claim 1, wherein the device comprises a cavity that extends throughthe engagement surfaces and the wedge.
 10. The device recited in claim1, wherein the device is kidney-shaped.
 11. The device recited in claim1, wherein the actuator is a screw.
 12. The device recited in claim 1,wherein the actuator is a screw having a ball tip.
 13. The devicerecited in claim 1, wherein the device comprises a cavity that extendsthrough the engagement surfaces.
 14. The device recited in claim 1,further comprising a pin that is positioned in the wedge and translateswithin one of the endplates as the device moves between the first andsecond configurations.
 15. A device to space apart vertebral members,the device comprising: a frame having an interior cavity; a firstendplate comprising a first ramp; a second endplate comprising a secondramp; a wedge positioned between the endplates, the wedge comprising afirst inclined portion that slidably engages the first ramp and a secondinclined portion that slidably engages the second ramp; and a pivotcoupled to the frame and an actuator that extends through the pivot,wherein the wedge is movable relative to the endplates to move thedevice between a first configuration having a first height between theendplates and a second configuration having an increased second heightbetween the endplates, the ramps and the wedge being positioned withinthe interior cavity as the device moves between the first and secondconfigurations, and wherein rotation of the actuator relative to thepivot translates the actuator such that the wedge moves relative to theendplates to move the device between the first and secondconfigurations.
 16. The device recited in claim 15, wherein the actuatoris a screw having a ball tip, the ball tip being positioned within anarcuate track in the wedge.
 17. The device recited in claim 15, furthercomprising a pin that is positioned in an aperture of the wedge andtranslates within a slot of one of the endplates as the device movesbetween the first and second configurations.
 18. The device recited inclaim 15, further comprising a first pin that is positioned within afirst aperture of the wedge and translates within a first slot of thefirst endplate as the device moves between the first and secondconfigurations and a second pin that is positioned within a secondaperture of the wedge and translates within a second slot of the secondendplate as the device moves between the first and secondconfigurations.
 19. A kidney-shaped device to space apart vertebralmembers, the device comprising: a first endplate comprising a firstramp; a second endplate comprising a second ramp; a wedge positionedbetween the endplates, the wedge comprising a first inclined portionthat slidably engages the first ramp and a second inclined portion thatslidably engages the second ramp; and a pin positioned in an aperture ofthe wedge, wherein the device comprises a cavity that extends throughthe engagement surfaces and the wedge, bone graft being positionedwithin the cavity, and wherein the wedge is movable relative to theendplates to move the device between a first configuration having afirst height between the endplates and a second configuration having anincreased second height between the endplates, and wherein the pintranslates within a slot of one of the endplates as the device movesbetween the first and second configurations.
 20. The kidney-shapeddevice recited in claim 19, wherein the first endplate extends parallelto the second endplate when the device is in the first and secondconfigurations.